FDA Medical Device Recalls (openFDA)
Datascope Corp: 10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature.
- Recall number
- Z-0916-03
- Recalling firm
- Datascope Corp
- Product
- 10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature.
- Status
- Terminated
- Initiated
- 2003-03-21
- Posted
- 2003-06-05
- Terminated
- 2003-08-01
- Reason
- 10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.
- Root cause
- Other
- Action
- Recall letters were sent via US mail return receipt requested to customers on 3/31/2003. Sales representatives received a letter on 3/28/2003.
- Quantity
- 60 units
- Distribution
- Product was distributed domestically to hospitals nationwide. There are no US government or foreign consignees.
- Lot, serial or model codes
- REF or Order #0684-00-0195-02; P/N #0684-00-0438; Lot #BRV; Exp. Date 03/03/05.
- 510(k) numbers
- K964987
- PMA numbers
- not on file
- Product code
- DSP
- Firm FEI
- 1000222374
- Firm city
- Fairfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28