Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma… recallZ-1922-2008 · 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-1922-2008
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: 147 US, 19 OUS
Product code: DTZ
FDA submissions: K000430
Distribution: Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.

Product description

Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda BioActive Surface, Catalog Number: CB511, CB5201R14, and CB5227R4.

Code information (models, lots, serial numbers)

Catalog / Lot: CB511 / 9816345, CB5201R14 / 9828465, CB5227R4 / 9879857

Other devices under the same FDA submission

1 device cleared under K000430 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Affinity® CB511
Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 48100).

Z-1920-2008 · Terminated
Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass Oxygenator, Catalog Numbers: CB0B90R3, CB0L44R15, CB0X97R10, CB1V99R2, CB1Y06R14, CB1Z42R15, CB…
Z-1923-2008 · Terminated
Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog Number: CB67532
Z-1925-2008 · Terminated
Medtronic Arterial Cannula Straight Beveled tip, for Cardiopulmonary Bypass. Catalog Numbers: CB71424, CB77008, and CB77010.
Z-1927-2008 · Terminated
Medtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass. Catalog Numbers: CB81120 and CB87022.
Z-1928-2008 · Terminated
Medtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary Bypass. Catalog Numbers: CB96345-023, CB96345-023, and CB96345-029.
Z-1929-2008 · Terminated
Medtronic Bio-Medicus Percutaneous Cannula & Introducer Set, Catalog Number: CB96535-015

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.

How recalls are matched to devices · Editorial policy · Report an error on this page