Recall Z-2577-2021— IMPERATIVE CARE INC
Class I · Completed
Class I FDA medical device recall by IMPERATIVE CARE INC, initiated 2021-08-13. It names 3 FDA 510(k) clearances: K210996, K202182, K183043. 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.. Reason: There is a potential for distal end of catheters to fracture and become detached..
- Recalling firm
- IMPERATIVE CARE INC
- Classification
- Class I
- Status
- Completed
- Initiated
- 2021-08-13
- Firm location
- Campbell, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K210996 — ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
- K202182 — ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
- K183043 — 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
There is a potential for distal end of catheters to fracture and become detached.
Data sourced from openFDA. This site is unofficial and independent of the FDA.