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Mega(Tm) 7.5FR. 30cc Intra-Aortic Balloon Catheter and Accessories, Mega(Tm) 7.5FR. 40cc Intra-Aortic Balloon Catheter

by Datascope Corp., Cardiac Assist Division

510(k) K120868

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK120868 Date20 Apr 2012ClearedStatusActive

Recalls

7 recalls · 4 ongoing · FDA

    • Ongoing Z-2219-2023 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.

  • 3 recalls, same reason

    • Ongoing Z-2833-2020 FDA Class II initiated 27 Jul 2020
    • Ongoing Z-2832-2020 FDA Class II initiated 27 Jul 2020
    • Ongoing Z-2831-2020 FDA Class II initiated 27 Jul 2020

    Potential Endotoxin Contamination

  • 2 recalls, same reason

    • Terminated Z-1384-2018 FDA Class II initiated 21 Feb 2018
    • Terminated Z-1383-2018 FDA Class II initiated 21 Feb 2018

    The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.

    • Terminated Z-1935-2016 FDA Class II initiated 13 May 2016

    It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).

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  • Withdrawn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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