Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 37 of 138
Epimed International
Class II Completed
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Reason: Potential for stylet to protrude from the distal end of the catheter
Z-2313-2021 August 25, 2021 Farmers Branch, TX
Epimed International
Class II Completed
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Reason: Potential for stylet to protrude from the distal end of the catheter
Z-2312-2021 August 25, 2021 Farmers Branch, TX
Delta Med SpA
Class II Ongoing
DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i)...
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2297-2021 August 25, 2021 Viadana, N/A
Delta Med SpA
Class II Ongoing
NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2303-2021 August 25, 2021 Viadana, N/A
Delta Med SpA
Class II Ongoing
NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2302-2021 August 25, 2021 Viadana, N/A
Boston Scientific Corporation
Class II Ongoing
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Reason: Potential for leaks and loosening at the patient catheter connection
Z-2327-2021 August 25, 2021 Maple Grove, MN
Delta Med SpA
Class II Ongoing
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2300-2021 August 25, 2021 Viadana, N/A
Delta Med SpA
Class II Ongoing
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2305-2021 August 25, 2021 Viadana, N/A
Merit Medical Systems, Inc.
Class II Terminated
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads an...
Reason: There is a potential that 7F sheaths are packaged as 10F sheaths.
Z-2238-2021 August 18, 2021 South Jordan, UT
Edwards Lifesciences, LLC
Class II Terminated
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO,...
Reason: There is a potential for internal leaks within catheters.
Z-2281-2021 August 18, 2021 Irvine, CA
Merit Medical Systems, Inc.
Class II Terminated
Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads ...
Reason: There is a potential that 7F sheaths are packaged as 10F sheaths.
Z-2239-2021 August 18, 2021 South Jordan, UT
Edwards Lifesciences, LLC
Class II Terminated
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI:...
Reason: There is a potential for internal leaks within catheters.
Z-2279-2021 August 18, 2021 Irvine, CA
Edwards Lifesciences, LLC
Class II Terminated
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI...
Reason: There is a potential for internal leaks within catheters.
Z-2278-2021 August 18, 2021 Irvine, CA
Edwards Lifesciences, LLC
Class II Terminated
Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01...
Reason: There is a potential for internal leaks within catheters.
Z-2282-2021 August 18, 2021 Irvine, CA
Edwards Lifesciences, LLC
Class II Terminated
Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US
Reason: There is a potential for internal leaks within catheters.
Z-2280-2021 August 18, 2021 Irvine, CA
Cordis Corporation
Class II Terminated
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Reason: The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to...
Z-2235-2021 August 18, 2021 Miami Lakes, FL
Edwards Lifesciences, LLC
Class II Terminated
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US
Reason: There is a potential for internal leaks within catheters.
Z-2283-2021 August 18, 2021 Irvine, CA
Arrow International Inc
Class II Ongoing
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or E...
Reason: Marketed without a 510K
Z-2068-2021 July 21, 2021 Reading, PA
Cordis Corporation
Class II Terminated
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Reason: The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Z-2079-2021 July 21, 2021 Miami Lakes, FL
Arrow International Inc
Class II Ongoing
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac...
Reason: Marketed without a 510K
Z-2069-2021 July 21, 2021 Reading, PA
Arrow International Inc
Class II Ongoing
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recordin...
Reason: Marketed without a 510K
Z-2070-2021 July 21, 2021 Reading, PA
Arrow International Inc
Class II Ongoing
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardi...
Reason: Marketed without a 510K
Z-2071-2021 July 21, 2021 Reading, PA
RanD S.r.l.
Class II Terminated
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
Reason: The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots...
Z-2049-2021 July 21, 2021 Medolla
Medtronic Heart Valves Division
Class II Ongoing
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Reason: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Z-2041-2021 July 14, 2021 Santa Ana, CA
Medtronic Heart Valves Division
Class II Ongoing
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
Reason: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Z-2043-2021 July 14, 2021 Santa Ana, CA