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DF4 Helix Locking Tool

CENTERPOINT SYSTEMS LLC · Model A002HELX · UDI-DI 00810024671724

DWS Prescription

510(k) clearances

845

Adverse events (11 deaths)

Recalls

308

Facilities

Description

The DF4 Helix Locking Tool is a sterile, single-use device compatible with pacing and/or defibrillator leads with an extendable-retractable fixation helix and an DF4 connector with terminal pin. The DF4 Helix Locking Tool is press-fit to the lead terminal pin to fix in place or, upon rotation, transfer torque to the helix electrode. The lead helix may be extended or retracted based on the direction of torque applied. The tool may also guide stylet insertion into the lead.

Recalls

Date	Firm	Reason
2025-03-27	Galt Medical Corporation	Due to a potential open seal in the sterile barrier packaging.
2023-07-24	Cook Vandergrift, Inc.	Sterility of device may be compromised due to breach of the chevron seal of the packaging
2023-06-28	Maquet Cardiovascular, LLC	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positi
2023-06-28	Maquet Cardiovascular, LLC	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positi
2023-06-28	Maquet Cardiovascular, LLC	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positi
2023-06-28	Maquet Cardiovascular, LLC	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positi
2022-02-09	Maquet Cardiovascular, LLC	Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
2020-02-06	Deroyal Industries, Inc. Lafollette	The sterile packaging has the potential to be compromised.
2020-01-13	TELEFLEX MEDICAL INC	There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
2020-01-13	TELEFLEX MEDICAL INC	There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.