Cardiac Sheath Introducer Devices Recalled Due to Size Mislabeling
Merit Medical Systems recalls 760 units of Prelude SNAP Splittable Sheath Introducer (7F) due to packaging errors where devices are labeled as 10F instead of the correct 7F size.
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: FDA Class II recall of a high-risk cardiac medical device involving size mislabeling. Although no injuries or illnesses have been reported, the incorrect size labeling poses material risk in a critical application where proper sizing is essential for safe device placement and function. This fits the rubric criterion of "risk-of-harm products where injury has not yet been reported."
Plain-English summary
Merit Medical Systems, Inc. is recalling 760 units of Prelude SNAP Splittable Sheath Introducer, Reference PLS-1007, size 7F, Standard Length 13 cm, due to a packaging issue where 7F sheaths are potentially packaged as 10F sheaths.
The Prelude SNAP Splittable Sheath Introducer is a sterile medical device designed for the introduction of pacing leads and catheters to the heart and coronary venous system. Size is critical for proper device placement and function. If the device is labeled with the incorrect size, clinicians may select or receive the wrong size, potentially leading to improper catheter introduction and device malfunction.
The recalled units include Lot I2059849 and were distributed across the United States and Norway. Affected healthcare providers should quarantine affected devices and consult with Merit Medical Systems regarding replacement or verification of correct sizing.
No injuries or illnesses have been reported to date.
The recalled product
- Product
- Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- Affected units
- 760
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 (1)
- Lot # I2059849
Distribution
Part of a larger recall action
This product is one of 2 recalled by Merit Medical Systems, 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.
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