Heartstring III 4.3 mm seal systems recalled over loading and deployment failures
Heartstring III Proximal Seal Systems, 4.3 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 12,471 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; failure to achieve hemostasis during aortic surgery is a potential harm and no injuries are reported.
Plain-English summary
The Heartstring III Proximal Seal System, 4.3 mm, an intravascular anastomosis occluder, model HSK-3043, UDI 00607567700321, is being recalled. Affected serial numbers include 3000379223, 3000382433, 3000385929, 3000391405 and 3000399719, with the full list in the recall notice. The recall covers 12,471 units, of which 6,565 are in the United States and 5,906 outside it.
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. The FDA classified the action as Class II.
Hospitals and cardiac surgery units holding affected serial numbers should quarantine them and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Cardiac Surgery
- Hazard
- deployment-failure
- hemostasis
- vascular-occluder
- class-ii
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 (20)
- Model No. HSK-3043
- UDI: 00607567700321
- Serial No. 3000379223
- 3000382433
- 3000385929
- 3000391405
- 3000399719
- 3000404541
- 3000406469
- 3000408189
- 3000411816
- 3000414253
- 3000414613
- 3000415212
- 3000419765
- 3000421682
- 3000422957
- 3000427645
- 3000428019
- 3000429074
Distribution
Distributed nationwide across the United States.
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