Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vascu

FDA device recall Z-1041-2024 · posted 2024-02-08 · Open, Classified

Recall details

Recalling firm

BALT USA, LLC

Reason for recall

Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.

Action taken

On 01/03/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via priority mail to customers informing them that Balt USA has became aware of a situation where discoloration along the delivery system pusher component of the Optima Coil System was identified during in-house inspection of released finished good products. The discoloration was observed on the outside of the PET jacket along the hypotube component. Customers are instructed to: 1) Stop or cease use of the affected recall product. 2) Inform their hospital staff, such as safety officers, pharmacists, purchasing agent, head of neuroradiology and the neuroradiology staff, physicians including but not limited to endovascular neurosurgeons and interventional neurologists, as well as any other person if deemed necessary of the recall. 3) Identify and locate the Optima Coil System products concerned by this recall procedure. 4) Collect and put in quarantine the Optima Coil System products concerned by this recall procedure, then return them to Balt USA through the usual RGA (Return Goods Authorization) procedure by contacting Balt USA s Customer Service department. 5) Keep informed by Balt USA about the status of every unit of Optima Coil System products concerned by this recall procedure. For questions or additional assistance, contact Balt USA Quality Department at: Contact: Quality Department email: QA@baltgroup.com Balt USA, LLC 29 Parker | Irvine CA, 92618 | USA Telephone: +1 949.788.1443 | Fax: +1 949.788.1444

Root cause

Material/Component Contamination

Status

Open, Classified

Product code

HCG

Quantity affected

31785 coils

Distribution

U.S.: AZ, CA, CO, FL, GA, HI, IL, KS, MA, ME, MO, MS, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, VT, WI and Puerto Rico O.U.S.: Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominica

Date initiated

2024-01-03

Date posted

2024-02-08

Location

Irvine, CA

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