Z-1375-2016Class II

Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the...

Name: Z-1375-2016 Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the...
Creator: Merit Medical Systems, Inc.
Published: 2016-03-15
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2016-03-15 / Terminated / root cause: software

FDA source

Merit Medical Systems, Inc. began a recall of Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder... on 2016-03-15. FDA classified it as Class II and gives the reason as "Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. The curve...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1375-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-15
Posted: 2016-04-12
Terminated: 2016-08-22
Recalling firm: Merit Medical Systems, Inc.
Product: Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
Product code: DRC Trocar
Reason for recall: Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. The curve dimensional values on the labels of this lot incorrectly indicate a 50 curve, rather than the correct 86 curve
Root cause tag: software
FDA root cause: Software design
Action: The consignee was provided verbal and written notification of the field action on March 15, 2016. There was a total of one (1) consignee, an OEM customer in the USA, who received 25 units. Written notification included product identification information, instruction to immediately quarantine any devices and discontinue distribution, and instructions to initiate a product recall in accordance with their company's established policies for customers to whom they shipped the affected Merit product. An email notification was sent to the Merit sales representative of the affected account. The sales representative was provided a Customer Response Form applicable to their account. The sales representative was instructed to assist the account with the completion of the Customer Response Form and the return of the affected units back to the Merit Field Assurance Department.
Quantity in commerce: 25
Distribution: Distributed to one customer in the US.
Product codes and lots: Lot Q823423, Exp 7/31/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1375-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1375-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-12

Product code DRC

K011727Class IITransseptal Needle/trocarThomas Medical Products, Inc. / cleared 2002-05-02

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)