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Sensation Plus 7.5FR. 40cc Intra-Aortic Balloon (Iab) Catheter and Accessories

by Datascope Corp., Cardiac Assist Division

510(k) K122628

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 12 Oct 2026. What this means

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK122628 Date6 Sep 2012ClearedStatusActive

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-2221-2023 FDA Class II initiated 23 Jun 2023

    During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

    • Ongoing Z-2836-2020 FDA Class II initiated 27 Jul 2020

    Potential Endotoxin Contamination

    • Terminated Z-1966-2019 FDA Class II initiated 28 May 2019

    The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DSP
Device Class
Class II
Regulation
21 CFR Part 870.3535
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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