Edwards Lifesciences Recalls Proplege Coronary Sinus Catheters Due to Leakage
Edwards Lifesciences is recalling Proplege Coronary Sinus Catheters, model PR9, because of confirmed blood leakage through the hemostasis valve in the kitted introducer.
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 3/5 (High).
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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (blood leakage) where specific injury counts are not reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Edwards Lifesciences, LLC is recalling specific units of the Proplege Coronary Sinus Catheter, model PR9. The recall involves 807 units of the 11 French Introducer, which is kitted with the PR9 catheter. These devices are used to provide access to the central venous circulation and facilitate retrograde cardioplegia during cardiopulmonary bypass surgery.
The recall was initiated due to confirmed reports of blood leakage through the hemostasis valve in the introducer sheath kit. The affected lot numbers are 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, and 59423200.
The affected products were distributed worldwide, including nationwide in the United States and in Canada. Healthcare providers and facilities should stop using the affected devices and contact Edwards Lifesciences for further instructions on the recall.
The recalled product
- Product
- Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter…
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Affected units
- 807
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 (12)
- Model PR9
- lot numbers: 59385159
- 59385164
- 59385204
- 59398000
- 59398006
- 59398008
- 59400402
- 59423199
- 59423200
- 59385159
- 59398006.
Distribution
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