# ACUITY™ Spiral 4591 > Active: United States. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [Boston Scientific](https://devicerts.com/manufacturers/boston-scientific) (United States) - Device class: Class III (US FDA) - FDA product code: LWP, NIK - GMDN: Endocardial/interventricular septal pacing lead (35223) ## Registrations and authorizations - **GUDID** · GUDID listing · United States · UDI-DI 00802526422980 · listed 2014-09-24 · status: Listed (GUDID: in commercial distribution) - **GUDID** · FDA PMA · United States · P010012 · decision 2002-05-02 · decision APPR · status: Active · from GUDID ## Recalls - Z-1671-2022 · Class II · ongoing · initiated 2022-07-07 · matched through shared submission P010012, may concern other models: There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators. - Z-0080-2018 · Class II · terminated · initiated 2017-10-04 · matched through shared submission P010012, may concern other models: The devices have an incorrect firmware configuration. - Z-0079-2018 · Class II · terminated · initiated 2017-10-04 · matched through shared submission P010012, may concern other models: The devices have an incorrect firmware configuration. - Z-0081-2018 · Class II · terminated · initiated 2017-10-04 · matched through shared submission P010012, may concern other models: The devices have an incorrect firmware configuration. - Z-1556-2010 · · terminated · initiated 2010-03-15: Boston Scientific Corporation has stopped shipment and is retrieving unimplanted devices from US hospital shelves of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) after determining that some manufacturing process changes were not submitted for approval to the US Food & Drug Administration. - Z-0609-2010 · · terminated · initiated 2009-12-01: BSC CRM provided important patient management information regarding Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs. Engineering simulations and field reports indicate that in some cases, implanted devices may encounter sufficient mechanical stress to weaken the bond between the header and case when positioned subpectorally. A weakened header bond may alter lead impedance and introduce noise - Z-1055-2007 · · terminated · initiated 2007-03-23 · matched through shared submission P010012, may concern other models: Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months. - Z-1049-2007 · · terminated · initiated 2007-03-23 · matched through shared submission P010012, may concern other models: Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months. - Z-1052-2007 · · terminated · initiated 2007-03-23 · matched through shared submission P010012, may concern other models: Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months. - Z-1047-2007 · · terminated · initiated 2007-03-23 · matched through shared submission P010012, may concern other models: Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months. - Z-1053-2007 · · terminated · initiated 2007-03-23 · matched through shared submission P010012, may concern other models: Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months. - Z-1054-2007 · · terminated · initiated 2007-03-23 · matched through shared submission P010012, may concern other models: Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months. - Z-0047-2008 · · terminated · initiated 2007-03-16: Atypical Charge Time Behavior: 1)-End of Life (EOL) or ERI is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2)- Extended ERI charge time limits: Charge times during mid-life may remain below a normal extension of the ERI charge time . \*\*\*\*\*\* Prophylactic replacement of these devices prior to ERI is not recommended. As stated in the Product Upd - Z-1288-06 · · terminated · initiated 2006-05-15 · matched through shared submission P010012, may concern other models: Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. If function of this low voltage capacitor is compromised, the battery may deplete prematurely. - Z-0825-06 · · terminated · initiated 2006-04-07 · matched through shared submission P010012, may concern other models: 77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications. - Z-0826-06 · · terminated · initiated 2006-04-07 · matched through shared submission P010012, may concern other models: 77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications. - Z-0827-06 · · terminated · initiated 2006-04-07 · matched through shared submission P010012, may concern other models: 77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications. - Z-0863-06 · · terminated · initiated 2006-03-11 · matched through shared submission P010012, may concern other models: Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted. - Z-0891-06 · · terminated · initiated 2005-09-30 · matched through shared submission P010012, may concern other models: Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier. ## Identity - Trade name: ACUITY™ Spiral [FDA GUDID (AccessGUDID)] - Generic name: Endocardial/interventricular septal pacing lead [FDA GUDID (AccessGUDID)] - Model / reference: 4591 [FDA GUDID (AccessGUDID)] ## Identifiers - Primary DI / UDI-DI: 00802526422980 [FDA GUDID (AccessGUDID)] - PMA number: P010012 [FDA GUDID (AccessGUDID)] - FDA product code: LWP [FDA GUDID (AccessGUDID)] - GMDN term: Endocardial/interventricular septal pacing lead (35223) [FDA GUDID (AccessGUDID)] ## Classification - Device class: Class III [FDA GUDID (AccessGUDID)] - GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)] ## Properties - Supplied sterile: Yes [FDA GUDID (AccessGUDID)] - Single use: Yes [FDA GUDID (AccessGUDID)] - Implantable: Yes [FDA GUDID (AccessGUDID)] - Prescription use: Yes [FDA GUDID (AccessGUDID)] - Combination product: Yes [FDA GUDID (AccessGUDID)] - Serial number: Yes [FDA GUDID (AccessGUDID)] - Expiration date: Yes [FDA GUDID (AccessGUDID)] - Sterilise before use: No [FDA GUDID (AccessGUDID)] - Contains latex: No [FDA GUDID (AccessGUDID)] - Over-the-counter: No [FDA GUDID (AccessGUDID)] - Convenience kit: No [FDA GUDID (AccessGUDID)] - HCT/P: No [FDA GUDID (AccessGUDID)] - Premarket exempt: No [FDA GUDID (AccessGUDID)] - Lot / batch number: No [FDA GUDID (AccessGUDID)] - Manufacturing date: No [FDA GUDID (AccessGUDID)] ## Source and citation - Cite as: ACUITY™ Spiral 4591, Boston Scientific. deviCERTS medical device catalogue. https://devicerts.com/devices/acuity-spiral-4591 (data as of 2026-11-14). - Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/) - Registry records last synced: 2026-10-22 - Statuses computed as of: 2026-11-14 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms. - Attribution: DevicErts, https://devicerts.com/devices/acuity-spiral-4591 - Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.