Class II — Datascope Corporation
| Recalling firm | Datascope Corp. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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). |
| Product | MEGA® 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK® MEGA® 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK® MEGA® 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK® MEGA® 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK® & APA |
| Quantity | 31,030 units (US); 15,604 units (OUS) |
| Distribution | Worldwide Distribution. |
| Initiated | 2016-05-13 |
| Classified | 2016-06-08 |
| Terminated | 2019-03-22 |
| Recall number | Z-1935-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Datascope Corporation (Z-1935-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74225/
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