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Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

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Abstract

Firm Announcement Date:
November 12, 2018
FDA Publish Date:
June 06, 2019
Product Kind:
Medicine

Purpose for Announcement:
Firm Title:
Oscor Inc.
Model Title:
Product Description:

Product Description

Short-term Bipolar Pacing Lead, Mannequin TB


Firm Announcement

On September 26, 2018 Oscor notified prospects of a recall for sure tons (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As a part of the recall correction actions, Oscor is retrieving any remaining stock out within the subject. The recall scope is being expanded to incorporate expired stock for gadgets distributed between December 21, 2011 to Might 17, 2018. The recall growth is to make sure correct disposition of expired models. The FDA has been notified and is conscious Oscor Inc. is voluntarily taking this motion.

INTENDED USE:

The Short-term Bipolar Pacing Lead, Mannequin TB is used transvenously for momentary pacing and sensing of the guts together with a appropriate exterior pulse generator.

DEVICE DESCRIPTION:

The momentary pacing lead is a bipolar lead with depth markings. The proximal finish of the lead contains two 2mm (unshrouded) connectors which match on to most pulse mills or extension cable. The French dimension is printed on the lead hub.

REASON FOR THE VOLUNTARY PRODUCT REMOVAL:

Throughout the usage of some TB – Short-term Bipolar Pacing Leads, that includes the 2mm unshrouded connectors, the connector cap housing (see Image 1, No. 2 Pin Cap and Cowl) might slide and probably expose the connection wire. In some cases, this will trigger the wire to be extra vulnerable to lack of connectivity or breakage throughout motion of the cables inflicting interruption of the pacing system. The evaluation of the returned gadgets attributed the failure to a design change of the cap housing of the pins. Within the final six years, a complete of 4 critical accidents had been reported to Oscor which had been attributed to a connector cap malfunction inflicting the lead connector to separate throughout use probably resulting in an interruption of the pacing system. No deaths had been reported; nonetheless the danger for critical harm and/or dying is a priority if the connectors separates throughout use.

EVENT DESCRIPTION: Throughout the usage of some TB – Short-term Bipolar Pacing Leads, that includes the 2mm unshrouded connectors, the connector cap housing (see Image 1, No. 2 Pin Cap and Cowl) might slide and probably expose the connection wire. In some cases, this will trigger the wire to be extra vulnerable to lack of connectivity or breakage throughout motion of the cables inflicting interruption of the pacing system.

REASON FOR RECALL: Within the final six years, a complete of 4 critical accidents had been reported to Oscor which had been attributed to the above connector cap malfunction. No deaths had been reported; nonetheless the danger for critical harm and/or dying is a priority if the connectors separates throughout use.

WARNING:

For pacing dependent sufferers, an interruption of pacing system may end in critical harm or dying if not detected. Steady monitoring is required.

MODEL NUMBERS:

GTIN Mannequin Quantity Description Specs
      French dimension Curve Kind
00836559009726 020004 TB LEAD 4F UN-SHROUDED 4F Straight
00836559009733 020005 TB LEAD 5F UN-SHROUDED 5F Straight
00836559009740 020006 TB LEAD 6F UN-SHROUDED 6F Straight
00836559009788 020010 TB LEAD 4F UN-SHROUDED 4F Atrial J
00836559009795 020011 TB LEAD 5F UN-SHROUDED 5F Atrial J
00836559009801 020012 TB LEAD 6F UN-SHROUDED 6F Atrial J
00836559009856 020017 TB LEAD 5F UN-SHROUDED 5F 60° Curve
00836559009863 020018 TB LEAD 6F UN-SHROUDED 6F 60° Curve
00836559009900 020022 TB LEAD 4F UN-SHROUDED 4F Proper Coronary heart
00836559009917 020023 TB LEAD 5F UN-SHROUDED 5F Proper Coronary heart
00836559009924 020024 TB LEAD 6F UN-SHROUDED 6F Proper Coronary heart
00836559009030 TBK04110USG TB LEAD 4F UN-SHROUDED CONVENIENCE KIT 4F Straight
00836559009054 TBK05110USG TB LEAD 5F UN-SHROUDED CONVENIENCE KIT 5F Straight
00836559009078 TBK06110USG TB LEAD 6F UN-SHROUDED CONVENIENCE KIT 6F Straight
00885672007027 TBVK04110USG TB LEAD 4F UN-SHROUDED CONVENIENCE KIT 4F 60° Curve
00885672007034 TBJK04110USG TB LEAD 4F UN-SHROUDED CONVENIENCE KIT 4F Atrial J
00885672004378 TBRHK04110USG TB LEAD 4F UN-SHROUDED CONVENIENCE KIT 4F Proper Coronary heart
00885672103682 TBRHK06110USG TB LEAD 6F UN-SHROUDED CONVENIENCE KIT 6F Proper Coronary heart
The Fashions listed under weren’t a part of the unique press launch issued by Oscor Inc. on September 24, 2018.
00836559009849 020016 TB LEAD 4F, UNSHOURDED 4F 60° Curve
00885672004354 TBVK06110USG TB LEAD 6F UN-SHROUDED CONVENIENCE KIT 6F 60° Curve
00885672004392 TBRHK05110USG TB LEAD 5F UN-SHROUDED CONVENIENCE KIT 5F Proper Coronary heart

Buyer might contact Oscor’s Buyer Relations Group, Monday to Friday from 8:30AM to five:30PM Japanese Time at 727-937-2511 or through electronic mail at TB@oscor.com.

Healthcare professionals are inspired to report any malfunction and/or antagonistic occasions associated to the usage of these merchandise to the FDA’s MedWatch Security Info and Antagonistic Occasion Reporting Program:

Full and submit the report On-line: www.fda.gov/MedWatch/report.htm
Download form or name 1-800-332-1088 to request a reporting kind, then full and return to   the deal with on the pre-addressed kind, or submit by fax to 1-800-FDA-0178.

Original Press Release


Firm Contact Info

Customers:
Oscor’s Buyer Relations Group


Product Photographs



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