Skip to content

Rebel Monorail PtCr Coronary Stent System, REF / Catalog… recallZ-0580-2020 · Boston Scientific Corporation · initiated Oct 24, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

The firm, Boston Scientific, sent an "Urgent Medical Device Removal" letter dated 10/28/2019 overnight mail delivery to its customers. The letter stated the issue, identified affected product and stated that product should not be used. The customers were instructed, if any product is identified to segregate immediately and return to Boston Scientific. The customers were also instructed to Immediately complete the RECALL REMOVAL REPLY VERIFICATION TRACKING FORM and Scan/e-mail to: [email protected] OR Fax to #: 1-866-213-1806. This form must be completed and returned in all cases even if you do not have any affected product. If you are a distributor, please note that the removal notification should be forwarded to your customers. If you have any questions, contact Boston Scientific Quality Systems at 763-494-1133 or email: [email protected].

Recall details

Recall number
Z-0580-2020
Status
Terminated
Initiated by the company
Oct 24, 2019
Recalling firm
Boston Scientific Corporation
Quantity
14,145 devices total
Product code
MAF
FDA submissions
P130030
Distribution
Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.

Product description

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

24 devices cleared under P130030 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 84152).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page