Z-0580-2020Class II

Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The...

Name: Z-0580-2020 Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The...
Creator: Boston Scientific Corporation
Published: 2019-10-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2019-10-24 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of 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... on 2019-10-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0580-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-24
Posted: 2019-11-26
Terminated: 2023-03-20
Recalling firm: Boston Scientific Corporation
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.
Product code: MAF Stent, Coronary
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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].
Quantity in commerce: 14,145 devices total
Distribution: Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.
Product codes and lots: Lot / GTIN Number / Use By: 24077337 / 8714729843443 / 2019-07-17.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0580-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0577-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-26
Z-0578-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-26
Z-0579-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-26
Z-0580-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-26

Product code MAF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)