PASCAL Transcatheter Valve Repair System Affected by Manufacturing Defect
Edwards Lifesciences is recalling 92 units of the PASCAL Precision Transcatheter Valve Repair System due to a manufacturing defect in the release mechanism that could cause increased resistance and potential improper implant positioning.
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: This is a Class II recall of an implantable cardiac device where a manufacturing defect could result in improper device placement. No illnesses or injuries are reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score a 3 (High).
Plain-English summary
Edwards Lifesciences, LLC is recalling 92 units of the PASCAL Precision Transcatheter Valve Repair System (Models 20000ISM and 20000IS) due to a manufacturing defect affecting the release mechanism.
The defect causes resistance when users attempt to rotate the release knob to detach the implant from the delivery system. Additional torque required to initiate rotation of the release wire could cause the implant to rotate or be implanted in an unintended position during the valve repair procedure.
The affected units were distributed internationally to Austria, Belgium, Switzerland, Germany, Cyprus, Israel, United Kingdom, Greece, Ireland, Italy, Luxembourg, and Poland. Healthcare providers who have received these units should verify their serial numbers against the manufacturer's recall notice and take appropriate action regarding affected devices.
The recalled product
- Product
- PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiac Implant
- Hazard
- deployment-defect
- implant-malposition
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)
- Basic-UDI Code: 0690103S004PAS000BC. Model/Serial Numbers: 20000ISM/10844549
- 10844558
- 10921747
- 10700424
- 10809849
- 10809852
- 10844564
- 10864947
- 10903936
- 10903937
- 10921752
- 10921754
- 10865580
- 10921757
- 10921758
- 10921760
- 10700439
- 10776944
- 10776966
- 10776982
Distribution
Distribution scope not specified by the agency.
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