Medtronic Bio-Medicus Percutaneous Cannula & Introducer… recallZ-1929-2008 · Medtronic Perfusion Systems · initiated May 9, 2008
Terminated All recalls posted in July 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).
FDA root cause category: Nonconforming Material/Component
What the company is doing
Medtronic issued a Press Release on 05/07/2008. An Urgent Medical Device Recall letter was sent to customers on May 07, 2008. The letter identifies affected devices, explains the situation and requests that the impacted product be returned to Medtronic for disposal. The end user will be requested to complete a Recall Certificate acknowledging the receipt of this information.
Recall details
- Recall number
- Z-1929-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 9, 2008
- Posted by the FDA
- Jul 24, 2008
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 35 US, 2 OUS
- Product code
- DQY
- FDA submissions
- K884129
- Distribution
- Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
Product description
Medtronic Bio-Medicus Percutaneous Cannula & Introducer Set, Catalog Number: CB96535-015
Code information (models, lots, serial numbers)
Catalog / Lot: CB96535-015 / 9890940
Other devices under the same FDA submission
4 devices cleared under K884129 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BIO-MEDICUS® 96530-015Medtronic, Inc. · CATHETER, PERCUTANEOUS1 report
- BIO-MEDICUS® 96530-017Medtronic, Inc. · CATHETER, PERCUTANEOUS1 report
- BIO-MEDICUS® 96600-021Medtronic, Inc. · CATHETER, PERCUTANEOUS1 report
- Bio-Medicus™ CB96535-019Medtronic, Inc. · Catheter, percutaneous1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 48100).
- Z-1920-2008 · TerminatedMedtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass Oxygenator, Catalog Numbers: CB0B90R3, CB0L44R15, CB0X97R10, CB1V99R2, CB1Y06R14, CB1Z42R15, CB…
- Z-1922-2008 · TerminatedMedtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda BioActive Surface, Catalog Number: CB511, CB5201R14, and CB5227R4.
- Z-1923-2008 · TerminatedMedtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog Number: CB67532
- Z-1925-2008 · TerminatedMedtronic Arterial Cannula Straight Beveled tip, for Cardiopulmonary Bypass. Catalog Numbers: CB71424, CB77008, and CB77010.
- Z-1927-2008 · TerminatedMedtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass. Catalog Numbers: CB81120 and CB87022.
- Z-1928-2008 · TerminatedMedtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary Bypass. Catalog Numbers: CB96345-023, CB96345-023, and CB96345-029.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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