Surgical Stapler: da Vinci SureForm Recalled for Tissue Pushout and Bleeding
Intuitive Surgical recalled SureForm surgical staplers after tissue pushout events caused unexpected bleeding during procedures. The actual harm rate exceeded safety predictions.
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: FDA Class II recall where documented tissue pushout events during surgical use cause bleeding. The source confirms the actual rate of harm (bleeding) exceeds what was predicted in risk analysis, indicating significant functional failure in clinical use.
Plain-English summary
Intuitive Surgical has recalled da Vinci SureForm surgical staplers (models SureForm 45, SureForm 45 Curved-Tip, and SureForm 60) due to a malfunction identified during complaint data review. During stapler firing, tissue can be pushed distally within the jaws rather than being held in place and severed.
When this pushout event occurs, it can result in bleeding. The actual rate of harm associated with this bleeding exceeds the rate that was predicted in Intuitive Surgical's existing risk documentation.
The recall affects approximately 6,888 boxes containing 413,286 individual units, distributed worldwide and throughout all U.S. states and territories. All production lots of the affected models are included in this recall.
The recalled product
- Product
- da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460
- Manufacturer
- Intuitive Surgical, Inc.
Distribution
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