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Recall Observatory FDA recall evidence

Device product

Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.

Z-0580-2020

October 24, 2019

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 84152
Status
Terminated
Classification
Class II
Quantity
14,145 devices total
Official record key
device-enforcement:Z-0580-2020

Official wording

Reason: Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

Code information: Lot / GTIN Number / Use By: 24077337 / 8714729843443 / 2019-07-17.

Distribution pattern: Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.