Reperfusion Catheter Recalled Due to Risk of Distal End Fracture
Imperative Care ZOOM 71 Reperfusion Catheters are recalled due to potential for distal end fracture and detachment. This FDA Class I recall affects units distributed nationwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum score of 4. Although no illnesses or injuries have been reported and the hazard is described as a potential, the Class I designation itself indicates a reasonable probability of serious adverse health consequences, precluding any score below 4.
Plain-English summary
Imperative Care Inc. is recalling the ZOOM 71 Reperfusion Catheter (Model ICRC071137, TRX Tip, 137 cm, 6F) used for neurovascular procedures. The affected units total 3,118 and have been distributed nationwide.
There is a potential for the distal end of these catheters to fracture and become detached during use. The FDA has classified this as a Class I recall.
The affected lot numbers are: V2014902, F2026201, F2026802, F2028801, F2028901, F2029501, F2029701, F2030801, F2031101, F2035301, F2032502, F2100802, F2101301, F2104102, F2108101, F2108801, F2109601, F2109701, F2111101, F2110601, F2112301, F2113004, and F2112001.
Healthcare providers who have received affected catheters should contact Imperative Care Inc. for further instructions and replacement options.
The recalled product
- Product
- Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
- Manufacturer
- IMPERATIVE CARE INC
- Hazard
- Affected units
- 3,118
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Affected Lots: V2014902
- F2026201
- F2026802
- F2028801
- F2028901
- F2029501
- F2029701
- F2030801
- F2031101
- F2035301
- F2032502
- F2100802
- F2101301
- F2104102
- F2108101
- F2108801
- F2109601
- F2109701
- F2111101
- F2110601
Distribution
Distributed nationwide across the United States.
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