Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 34 of 138
W L Gore & Associates, Inc.
Class II Ongoing
REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within t...
Reason: Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Z-0167-2022 November 3, 2021 Flagstaff, AZ
W L Gore & Associates, Inc.
Class II Ongoing
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within ...
Reason: Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Z-0170-2022 November 3, 2021 Flagstaff, AZ
W L Gore & Associates, Inc.
Class II Ongoing
REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within t...
Reason: Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Z-0168-2022 November 3, 2021 Flagstaff, AZ
W L Gore & Associates, Inc.
Class II Ongoing
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within t...
Reason: Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Z-0172-2022 November 3, 2021 Flagstaff, AZ
W L Gore & Associates, Inc.
Class II Ongoing
REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within ...
Reason: Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Z-0171-2022 November 3, 2021 Flagstaff, AZ
W L Gore & Associates, Inc.
Class II Ongoing
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within t...
Reason: Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Z-0166-2022 November 3, 2021 Flagstaff, AZ
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
C315-HIS Delivery Catheter
Reason: Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
Z-0173-2022 November 3, 2021 Mounds View, MN
W L Gore & Associates, Inc.
Class II Ongoing
REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
Reason: Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Z-0164-2022 November 3, 2021 Flagstaff, AZ
W L Gore & Associates, Inc.
Class II Ongoing
REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within t...
Reason: Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Z-0169-2022 November 3, 2021 Flagstaff, AZ
ZOLL Circulation, Inc.
Class II Terminated
Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0050-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0043-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849...
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0039-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)008491110755...
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0044-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0064-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0060-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0065-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0063-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0049-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)0084911105...
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0054-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0059-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0047-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0055-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0062-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0053-2022 October 13, 2021 San Jose, CA
ZOLL Circulation, Inc.
Class II Terminated
ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Onl...
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0042-2022 October 13, 2021 San Jose, CA