Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

254 results found for pacemaker Page 5 of 11
Boston Scientific Corporation
Class II Ongoing
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
Reason: Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery dep...
Z-2000-2021 July 14, 2021 Saint Paul, MN
Boston Scientific Corporation
Class II Ongoing
Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
Reason: Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery dep...
Z-1998-2021 July 14, 2021 Saint Paul, MN
Boston Scientific Corporation
Class II Ongoing
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Reason: Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery dep...
Z-2002-2021 July 14, 2021 Saint Paul, MN
DeRoyal Industries Inc
Class I Terminated
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
Reason: DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupi...
Z-1832-2021 June 16, 2021 Powell, TN
St. Jude Medical, Cardian Rhythm Management Division
Class I Ongoing
ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
Reason: Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction...
Z-1530-2021 May 19, 2021 Sylmar, CA
St. Jude Medical, Cardian Rhythm Management Division
Class I Ongoing
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
Reason: Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction...
Z-1531-2021 May 19, 2021 Sylmar, CA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronizati...
Reason: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV...
Z-1526-2021 May 12, 2021 Mounds View, MN
BEMER INT. AG
Class II Terminated
Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professio...
Reason: There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker.
Z-1105-2021 February 17, 2021 Triesen, N/A
ROi CPS LLC
Class II Terminated
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, It...
Reason: Gauze sponges contained in custom kits may be flaking or fraying.
Z-0737-2021 January 6, 2021 Republic, MO
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Reason: Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
Z-1525-2020 March 25, 2020 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Reason: Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
Z-1524-2020 March 25, 2020 Mounds View, MN
Centurion Medical Products Corporation
Class II Terminated
Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIVERY INSTRUMENT TRAY MNS10620 PACEMAKER TRAY MNS10820 ENT/EPIS...
Reason: Incomplete seals on the sterile package may compromise the sterility
Z-1054-2020 February 12, 2020 Williamston, MI
AZIYO BIOLOGICS
Class II Terminated
BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); ...
Reason: Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
Z-0039-2020 October 16, 2019 Roswell, GA
AZIYO BIOLOGICS
Class II Terminated
CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); ...
Reason: Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
Z-0040-2020 October 16, 2019 Roswell, GA
Abbott Laboratories, Inc
Class II Terminated
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Reason: The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to ...
Z-2755-2019 October 2, 2019 Irving, TX
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Terminated
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
Reason: Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micr...
Z-2493-2019 September 18, 2019 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Terminated
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
Reason: Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micr...
Z-2492-2019 September 18, 2019 Mounds View, MN
American Contract Systems, Inc.
Class II Terminated
Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: P...
Reason: Potential that product has not reached complete sterilization,
Z-0964-2019 March 6, 2019 Bloomington, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0807-2019 February 20, 2019 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers:...
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0812-2019 February 20, 2019 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0811-2019 February 20, 2019 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0809-2019 February 20, 2019 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0810-2019 February 20, 2019 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0808-2019 February 20, 2019 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDR...
Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a d...
Z-0806-2019 February 20, 2019 Mounds View, MN