Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance
Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some cannula tips that can be dislodged.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of a dislodgable foreign substance in a device used during cardiac surgery poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns Antegrade Cardioplegia Cannula, specifically the X-COATED SMALL PATIENT PACK (Catalog number 71936-02, Lot number PC06). The recall involves 53,139 units distributed worldwide, including nationwide in the United States and in various international markets.
The recall was initiated after Terumo CVS identified the presence of a foreign substance on the inner surface of some cannula tips during production. A preliminary investigation determined that this substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, though its exact composition is not specified in the source text.
These devices are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, vent the left heart, and aspirate air from the aorta during cardiopulmonary bypass procedures. Healthcare facilities and distributors should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 53,139
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog number: 71936-02 and lot number: PC06
Distribution
Part of a larger recall action
This product is one of 20 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 20 products in this recall →Related recalls
Same manufacturer · Terumo Cardiovascular Systems Corporation
See all →- HighCDI OneView System BPM Probe temperature sensor measurement inaccuracy
FDA (Devices) · 2025-07-02
- HighTerumo CDI OneView Monitor Probe May Fail to Display Oxygen Saturation Data
FDA (Devices) · 2025-04-09
- HighCardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect
FDA (Devices) · 2024-04-10
- HighCAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding
FDA (Devices) · 2023-04-12
- HighTerumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding
FDA (Devices) · 2023-04-12
Same hazard · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- HighTerumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance
FDA (Devices) · 2012-06-27
- HighTerumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance
FDA (Devices) · 2012-06-27
- HighTerumo Recalls Sarns High-Flow Aortic Arch Cannula Kits Due to Foreign Substance
FDA (Devices) · 2012-06-27
- HighTerumo Recalls Sarns Flexible Arterial Cannula Due to Foreign Substance
FDA (Devices) · 2012-06-27
- ModerateTerumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate
FDA (Devices) · 2014-07-30
- ModerateTerumo Recalls Sarns Malleable Venous Return Cannulae Due to Particulate
FDA (Devices) · 2014-07-30