Z-0854-2011

Boston Scientific brand Matrix2 2D Standard SR Coils. Intended for embolization of certain intracranial...

Name: Z-0854-2011 Boston Scientific brand Matrix2 2D Standard SR Coils. Intended for embolization of certain intracranial...
Creator: Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
Published: 2010-10-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-10-19 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 began a recall of Boston Scientific brand Matrix2 2D Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in... on 2010-10-19. The reason FDA records is "The product appears to have premature degradation of the PGLA coating on the Matrix Coil". 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-0854-2011
Status: Terminated
Initiated: 2010-10-19
Posted: 2011-01-05
Terminated: 2012-01-27
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific brand Matrix2 2D Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
Product code: HGC Clamp, Uterine
Reason for recall: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
Quantity in commerce: 77,364 total units
Distribution: Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.
Product codes and lots: Material Product Description Catalog # Batch Numbers Expiry Date Matrix2¿ 2D Standard SR Coils 11286278,11535148,11975068,11975079, Oct2010 through M003470103SRO 470103-SR 11985922,12156355,12156606,12176009, 10mm x30cm 12330517,12356322,12392934,13602979 Jun2013 M003470308SRO Matrix2¿ 2D Standard SR Coils 470308-SR 11766418,11775113 May2011 through 3mm x8cm May2011 Matrix2¿ 2D Standard SR Coils 11423155,11766419,11836539,11963593, Dec2010 through M003470410SRO 470410-SR 12156359,12176012,12260125,12358023, 4mm x 10cm 12792923, 13705207 Jul2013 M003470510SRO Matrix2¿ 2D Standard SR Coils 470510-SR 12246984 Nov2011 5mmx10cm Matrix2¿ 2D Standard SR Coils 11344392,11697463,11873433,11967353, Nov2010 through M003470515SRO 470515-SR 12156357, 12156624, 12176010, 12259384, 5mmx15cm 12368756,12469532 Feb2012 M003470610SRO Matrix2¿ 2D Standard SR Coils 470610-SR 11800373,12520967 May2011 through 6mmx10cm Mar2012 M003470615SRO Matrix2¿ 2D Standard SR Coils 470615-SR 11377053,11985920,13201010,13220262 Dec2010 through 6mmx15cm Dec2012 Matrix2¿ 20 Standard SR Coils 11414852,11869799,11925610,11967354, Dec2010 through M003470620SRO 470620-SR 12156352,12156602,12156627,12176016, 6mm x20cm 12261954, 12359026, 13015863, 13115971 Nov2012 M003470715SRO Matrix2¿ 2D Standard SR Coils 470715-SR 11622085,12379812,12853030 Mar2011 through 7mm x 15cm Jul2012 M003470720SRO Matrix2¿ 2D Standard SR Coils 470720-SR 11800378,11984852,13201011,13220457 May2011 through 7mm x20cm Oec2012 Matrix2¿ 2D Standard SR Coils 11869790,11925609,11940380,11992208, Jun2011 through .J1003470730SRO 470730-SR 12156353,12156605,12176081,12176125, 7mm x30cm 12261953,12311506 Dec2011 M003470820SRO Matrix2¿ 2D Standard SR Coils 470820-SR 11248568,11946183,13201012 Oct2010 through 8mm x20cm Dec2012 Matrix2¿ 2D Standard SR Coils 11552555, 11925611, 11940382, 11975162, Feb2011 through M003470830SRO 470830-SR 12176014,12261957,12316891,12361241, 8mm x 30cm 12401291 Jan2012 M003470920SRO Matrix2¿ 2D Standard SR Coils 470920-SR 13602873 9mm x20cm Jun2013 Matrix2¿ 2D Standard SR Coils 11869791, 11925176, 11975070, 11975185, Jun2011 through M003470930SRO 470930-SR 12156358,12156615,12176011,12261956, 9mm x30cm 12370630 Jan2012

Product code HGC

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)