Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

254 results found for pacemaker Page 10 of 11
Boston Scientific Corporation
Class II Terminated
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
Reason: The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
Z-0620-2016 January 20, 2016 Saint Paul, MN
Boston Scientific Corporation
Class II Terminated
Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Reason: The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
Z-0621-2016 January 20, 2016 Saint Paul, MN
BC Group International Inc
Class III Terminated
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
Reason: Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Z-0457-2016 December 30, 2015 Saint Charles, MO
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostic...
Reason: Monitor Ceiling Suspension system may fall
Z-0348-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnost...
Reason: Monitor Ceiling Suspension system may fall
Z-0349-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper FD24 Allura Xper FD25 Product Us...
Reason: Monitor Ceiling Suspension system may fall
Z-0346-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xper FD20 BIPLANE R7.8 722013 Allura Xper FD20 ...
Reason: Monitor Ceiling Suspension system may fall
Z-0347-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnos...
Reason: Monitor Ceiling Suspension system may fall
Z-0350-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnos...
Reason: Monitor Ceiling Suspension system may fall
Z-0354-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics...
Reason: Monitor Ceiling Suspension system may fall
Z-0352-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, ...
Reason: Monitor Ceiling Suspension system may fall
Z-0351-2016 December 9, 2015 Andover, MA
Philips Medical Systems, Inc.
Class II Terminated
Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnosti...
Reason: Monitor Ceiling Suspension system may fall
Z-0353-2016 December 9, 2015 Andover, MA
Medtronic Inc.
Class II Terminated
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Reason: Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.
Z-0342-2016 December 9, 2015 Saint Paul, MN
DeRoyal Industries Inc
Class II Terminated
DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08D...
Reason: Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant du...
Z-0241-2016 November 18, 2015 Powell, TN
DeRoyal Industries Inc
Class II Terminated
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATR...
Reason: Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant du...
Z-0240-2016 November 18, 2015 Powell, TN
Medtronic Inc. Cardiac Rhythm Disease Management
Class II Terminated
Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. Th...
Reason: Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of...
Z-0022-2016 October 14, 2015 Saint Paul, MN
Resource Optimization & Innovation Llc
Class II Terminated
regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray ...
Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Z-0082-2016 October 14, 2015 Springfield, MO
St Jude Medical Cardiac Rhythm Management Division
Class II Terminated
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
Reason: Some devices exhibit backup VVI operation due to a backup reset.
Z-2784-2015 September 23, 2015 Sylmar, CA
BIOTRONIK, Inc.
Class II Terminated
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). All...
Reason: Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.
Z-2376-2015 August 19, 2015 Lake Oswego, OR
DeRoyal Industries Inc
Class II Terminated
Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932...
Reason: Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes
Z-1837-2015 July 1, 2015 Powell, TN
GE Healthcare
Class II Terminated
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Reason: The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor...
Z-1606-2015 May 20, 2015 Waukesha, WI
Medtronic Inc. Cardiac Rhythm Disease Management
Class II Terminated
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a...
Reason: Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connec...
Z-1356-2015 April 8, 2015 Saint Paul, MN
St Jude Medical Cardiac Rhythm Management Division
Class II Terminated
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Reason: Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assur...
Z-0949-2015 January 21, 2015 Sylmar, CA
Centurion Medical Products Corporation
Class II Terminated
Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
Reason: According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulat...
Z-0945-2015 January 14, 2015 Williamston, MI
Medtronic Inc. Cardiac Rhythm Disease Management
Class II Terminated
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial o...
Reason: Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have bee...
Z-1661-2014 June 4, 2014 Saint Paul, MN