Sphincterotomes recalled over devices that skipped a thermoforming step
Olympus is recalling 3,954 Single Use 3-Lumen Sphincterotome V units because devices which did not undergo thermoforming could deform and lose performance.
What this means for you
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: Scored 2 because the record's stated consequence is device deformation and loss of performance, with no patient harm or reported injury.
Plain-English summary
The Single Use 3-Lumen Sphincterotome V, model/catalog number KD-V411M-1520, is being recalled by Olympus Corporation of the Americas. The record describes the instruments as designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
The reason given in the enforcement record is that devices which did not undergo thermoforming could deform and lose performance.
The record lists 3,954 units and states these are outside the United States only, under material REF N5411630 and N1089910, UDI-DI 04953170380600, covering all lots with a valid expiration date. Distribution is given as worldwide, including nationwide in the United States across the states listed in the record and internationally. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is deformation and loss of performance, and no injuries are reported. Facilities should follow Olympus' instructions.
The recalled product
- Product
- Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 3,954
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 (6)
- Model/Catalog Number: KD-V411M-1520
- Material REF: (1) N5411630
- (2) N1089910
- UDI-DI: (1)04953170380600
- (2) N/A
- All Lots with a valid expiration date
Distribution
Part of a larger recall action
This product is one of 30 recalled by Olympus Corporation of the Americas 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.
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