Cook, Inc.
1700 N Curry Pike, Bloomington, IN, US
Registered product codes
1 product codes
Recent MDR events
34,775 on file
- SAFE-T-J FIXED CORE WIRE GUIDEJul 31, 2026Malfunction1820334-2026-00783
- MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SETJul 30, 2026Malfunction1820334-2026-00780
- FLEXOR ANSEL GUIDING SHEATHJul 30, 2026Malfunction1820334-2026-00781
- ADVANCE 18 LP LOW PROFILE BALLOON CATHETERJul 30, 2026Injury1820334-2026-00782
- NEFF PERCUTANEOUS ACCESS SETJul 29, 2026Malfunction1820334-2026-00770
- SOF-FLEX MULTI-LENGTH URETERAL STENT SETJul 29, 2026Malfunction1820334-2026-00771
- SOF-FLEX MULTI-LENGTH URETERAL STENT SETJul 29, 2026Malfunction1820334-2026-00772
- NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTORJul 29, 2026Malfunction1820334-2026-00773
- NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTORJul 29, 2026Malfunction1820334-2026-00774
- WAYNE PNEUMOTHORAX SETJul 29, 2026Malfunction1820334-2026-00775
Recalls
564 on file
- TerminatedDec 23, 2020
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
View FDA record ↗ - TerminatedDec 23, 2020
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
View FDA record ↗ - TerminatedDec 23, 2020
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
View FDA record ↗ - TerminatedDec 23, 2020
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
View FDA record ↗ - TerminatedDec 23, 2020
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
View FDA record ↗ - TerminatedDec 23, 2020
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
View FDA record ↗ - TerminatedDec 23, 2020
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
View FDA record ↗ - TerminatedDec 23, 2020
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
View FDA record ↗ - TerminatedDec 23, 2020
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
View FDA record ↗ - TerminatedDec 23, 2020
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
View FDA record ↗
Compliance history
Matched by FEI 3012766489.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.