Bard Inlay Optima Ureteral Stent Recalled for Labeling Update
C.R. Bard is recalling 75,089 Bard Inlay Optima ureteral stents to add a warning about potential knots during removal.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding a potential complication (knotting) during removal, which fits the criteria for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
C.R. Bard, Inc. is recalling 75,089 units of Bard Inlay Optima Multi-Length Ureteral Stents, including coated double pigtail stents and stents with sutures. The recall is due to a labeling deficiency where the Warnings/Precautions section did not adequately address the risk of encountering a knot during removal.
The affected products were distributed nationwide in the United States. The recall involves specific product codes: 777400, 777600, 777700, 777800, 778400, 778600, 778700, 778800, 786400, 786600, 786700, 786800, 787400, 787600, 787700, 787800, 788400, 788600, 788700, and 788800.
The recall action involves adding a statement to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal. Healthcare providers should check their inventory for these specific product codes and contact C.R. Bard for further instructions.
The recalled product
- Product
- Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
- Manufacturer
- C.R. Bard, Inc.
- Category
- Medical Device — Urology
- Hazard
- Affected units
- 75,089
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 (19)
- Product Codes: 777400
- 777600
- 777700
- 777800
- 778400
- 778600
- 778700
- 778800
- 786400
- 786600
- 786700
- 786800
- 787400
- 787600
- 787700
- 787800
- 788400
- 788600
- 788700 and 788800.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by C.R. Bard, Inc. 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 4 products in this recall →Related recalls
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